China's drug watchdog has
tightened controls on blood-based medicines by ordering that, from
June 1, every batch of human immunoglobulin must be checked and
approved before entering the market.
The regulation will be extended to all blood-based
drugs from Jan. 1, 2008, according to the State Food and Drug
Administration (SFDA).
Supervisors will carry out spot checks on the premises
of the blood drug producers.
They will be trained for the mission by local drug
watchdogs.
More than 80 supervisors from the SFDA had been sent
to 33 blood-based drug producers and 31 vaccine producers in 24
provinces, autonomous regions and municipalities by the end of
March.
Earlier this year, Guangdong Bioyee Pharmaceutical Co.
Ltd, a human immunoglobulin producer, was convicted of violating
production rules and had its manufacturing certificate
revoked.
The company's blood-based drug was sold in 12 regions
including Beijing, Shanghai, Fujian and Shandong. At least 90,000 doses of the drug
have been recalled, according to the SFDA.
(Xinhua News Agency May 19, 2007)
|